Tainted Heparin May Still be a Threat, Republican Lawmakers Say

Three years after tainted Baxter heparin caused serious, and in some cases fatal, allergic reactions in scores of patients, the Chinese companies that supplied Baxter with contaminated ingredients are still sending product to the U.S. According to a report from Bloomberg News, some Republican lawmakers have written to the U.S. Food & Drug Administration (FDA) asking why U.S. drugmakers have been told to avoid buying heparin ingredients from those firms.

As we’ve reported previously, Baxter International Inc. recalled nearly all its heparin injections in the U.S. in January 2008. The FDA eventually initiated 13 recalls of multiple contaminated medical products containing heparin from several companies. Eighty-one US deaths were ultimately tied to the contaminated heparin.

In March 2008, the FDA confirmed that it had found oversulfated chondroitin sulfate that was molecularly changed to mimic heparin’s blood-clotting properties in samples of the active ingredient used in Baxter heparin. Chondroitin sulfate costs a fraction of the ingredient usually used in heparin, and producers may have used it in an attempt to cut costs.

The counterfeit ingredient was supplied to Baxter by Changzhou SPL, a Chinese plant partially owned by Wisconsin-based SPL. Changzhou used two companies to supply it with a raw ingredient made from pig intestines, as is chondroitin sulfate. Those consolidators obtained the ingredient from unregulated workshops.

Now, several Republican lawmakers, led by Michigan Representative Fred Upton, chairman of the House Energy and Commerce Committee, have written a letter to FDA Commissioner Margaret Hamburg to voice concerns that the two unnamed companies are still importing product to the U.S. Upton’s committee reopened the tainted heparin investigation in February, according to Bloomberg.

â€œWe have reason to believe that these two Chinese firms are still supplying crude heparin that is being imported into the United States,â€ the lawmakers wrote Hamburg. â€œWe have seen no indication that the FDA has issued warning letters and/or import alerts to these firms even though FDA has issued warning letters and import alerts to other Chinese heparin firms.â€

A statement issued by the Committee also voices concern that tainted heparin could still pose a risk to the 12 million U.S. patients treated with the drug every year.

“Underscoring the urgency of the investigation, according to the October 2011 issue of The GMP Letter published by FDA News, the contaminated heparin crisis ‘could still be happening,'” the statement says. “The GMP Letter reports, â€˜Because of our inability to identify and trace in some cases who all the different members are of this particular supply chain,â€™ the agency believes the problem is not yet completely under control, Steven Wolfgang, acting associate director for risk science, intelligence and prioritization at (FDA) Center for Drug Evaluation and Researchâ€™s Office of Compliance, said Sept. 21 at the 20th annual Parenteral Drug Association/FDA joint regulatory conference in Washington, D.C.â€